FDA approves first human embryonic stem cell safety trial (3 days after Pres. Bush left)

Scientific American ^ | 1-23-09 | Jordan Lite

[STARWISE]

Federal regulators have green-lighted the first trial of an embryonic stem-cell treatment in humans.

The U.S. Food and Drug Administration (FDA) gave the go-ahead for Geron Corporation to start a phase I safety trial of its therapy GRNOPC1 for spinal cord injuries, the Menlo Park, Calif.–based company announced today.

It first sought permission for the trial four years ago and spent much of the last year trying to satisfy the FDA’s concerns about it.

"This marks the beginning of what is potentially a new chapter in medical therapeutics—one that reaches beyond pills to a new level of healing: the restoration of organ and tissue function achieved by the injection of healthy replacement cells,” Thomas Okarma, Geron's president and CEO, said in a statement today.

The trial will involve up to 10 patients and will test whether it is safe to inject nerve cells from embryos into the site of their injuries, according to Geron. A study published in 2005 in the Journal of Neuroscience found that giving rats the injections seven days after a spinal cord injury improved their motor function.

Wise Young, director of The W. M. Keck Center for Collaborative Neuroscience at Rutgers University, hailed the FDA’s decision, but says his expectations are tempered.

“It’s a big deal—it’s a long time in coming. There’s a lot of hope riding on this,” Young tells ScientificAmerican.com. But he cautions that people should not expect "a miraculous result" from this initial trial.

"I do believe cellular therapy will have a beneficial effect," he says, "but it’s very important to understand that we’re just starting. We have a long road to go.”

Geron and FDA officials told The Wall Street Journal that it was a coincidence that the announcement came just three days after George Bush left the White House. Bush restricted federal funding of embryonic stem cell research.

"The FDA looks to the science on these types of issues, and we approve [such applications] based on a showing of safety," FDA spokesperson Karen Riley told the Journal. “Political considerations have no role in this process."

Pres. Obama said during his campaign that he would lift the ban on federal funding of research on embryonic stem-cell lines produced after August 9, 2001. But he told CNN on January 18 that he may ask Congress to undo it.

Lawmakers passed legislation three times during the Bush administration that would have erased the limit and allowed research on stem cells from embryos at fertility clinics (with donors' consent) that would otherwise be discarded; Bush vetoed them all.

"I like the idea of the American people's representatives expressing their views on an issue like this," Obama told CNN.

That may not be a bad thing, Young says. “If he were to reverse this on his own, it takes Congress off the hook.

It’s much more important that Congress makes sure this doesn’t happen again,” he says. “What is worrisome is that if Obama did just reverse the rule, stem cells would be a political football in Congress to trade for something else.

It’s really important from the viewpoint of the advocacy community that legislation is passed so other presidents don’t come in and say, ‘I will forbid this.’”

[Intolerant in NJ]

So then, did they break the law with respect to the ban on embryonic stem-cell research?...one of the many, many, many big lies perpetated by the left is that there was such a "ban on embryonic stem-cell research" - of course by the evil George Bush who wanted to destroy science - as far as I understand the situation, the only "ban" involved was on the use of federal money to fund such research - it was perfectly OK to use private monies - there was also a limitation on initiating new families of embryonic stem cells, but there were already in existence at least five viable lines from which subject cells could be drawn - in fact at one point I recall hearing that there were colonies of such cells waiting to be "adopted" or employed in research projects - there was absolutely nothing in so far as the availability of embryonic stem cells which would have prevented a study such as the one mentioned in this story from having been undertaken four years ago, as the article states......

[RobbyS]

I’ve seen it. Yeah, dead on. An image that sticks with me was the video where Joe the Plumber looks him straight in the eye and sees... what? Not much, I gather from his reaction.

[RobbyS]

Obama simply does what his friends tell him what to do. I don't mean just his immediate circle, but the people he has been associating with for thirty years since he was a kid. His brain is like a sponge but it is saturated with prejudices.

[BykrBayb]

This looks to me like A Modest Proposal.

[pollywog]

so so sad!!!!! Judgement will fall on us!

[Syncro]

Wow, it took 3 days into the Obama Monarchy for them to do this?

The baby killer Present Obama is slipping!

It only took Arnold a few minutes into his administration as Guv here in California for him to approve 5 Billion for dead baby stem cell research, which will cost taxpayers 10 billion with interest.

So people are lined up to be experimented upon by allowing themselves to be injected with dead baby parts?

Unreal but expected.

[Syncro]

When do sperm and egg cease to be, and what kind of thing takes their place once they cease to be?

I have never seen a more simple straight forward answer to the question of when does life begin.

If two things cease to exist, and one thing exists from their union and if left alone it becomes you or me how much clearer can it be stated?

Thanks!

[sarah p]

The claim that a human embryo is not yet a life is flat out wrong.

Scientists all agree that single celled organisms, such as bacteria, are alive. Once fertilization is complete a single human cell is also alive. It fits all of the universally agreed on parameters to be classified as a life. These 7 processes are universally agreed on and are taught in every basic biology course. Let’s review them to show how an embryo and even a fertilized egg must be alive:

respiration = yes
nutrition = yes
excretion = yes
growth = yes
sensitivity = yes
movement = yes
reproduction = not yet
-However, the process of reproduction is not a required process for an individual to be alive, it is only required for continuation of the species. I am sure that not even a liberal would deny that a child is alive just because he/she has not yet matured to reproductive age.

Therefore, both embryos and fertilized eggs are alive because they fit the universally accepted scientific definition for life.

For all of you liberals out there, how can you deny that non-religious and scientific explanation?

[Humal]

This is what concerns me. IF he could be located; IF he has the sense to do what is needed (give the command); and IF he doesn't listen to Ayers, et al, instead, it could be countered. OTOH Sarah Palin was an opponent, and he may just decide to take the hit (scares me silly to think about it). I've been to Alaska, and it's an absolutely gorgeous, pristine place with good people. I'm hoping this is just Kim Jung Il flexing his muscles again.

[STARWISE]

It is .. profound. No further clarity necessary. It is starkly, simply the fact. I've never heard it said that way before either.

"When do sperm and egg cease to be, and what kind of thing takes their place, once they cease to be?"

[rdl6989]

bump to the top.

[LukeL]

While it was before my time I know there was great hype about interferon and how it was the cure for everything as it mimicked the body's own immune system, of course it was a near complete failure and only has very limited uses.

I should know I was on this to help shrink some benign tumors, only thing is it didn't do squat.

[SuziQ]

I liked that movie!

[SuziQ]

So then, did they break the law with respect to the ban on embryonic stem-cell research?

There was never a ban on embryonic stem cell research, just the creation of new embryos for it. Companies were allowed to work on it, on their own dime, using the available stem cell lines. President Bush simply disallowed Federal funding for the research.

[SuziQ]

Allowing religious based politics to dictate scientific research is akin to witchdoctors deciding what experiments will be conducted at the CERN Lab.

Again, companies were free to do any research they wanted, using available stem cell lines. That many didn't take that up, on their own dimes, spoke volumes. If they believed it was SO important and potentially groundbreaking, why didn't they invest any of their own R&D money in the research?

Interesting that you bring up CERN, because a leading scientist was trying to arrange to do some experiments there that could have been a very strong challenge to the Global Warming orthodoxy, but the funding was not approved. He was even told by a fellow scientist several years ago, that his conclusions were 'dangerous'. Say what?

Science has been politicized for years; it's not anything new, but there was NEVER a ban on embryonic stem cell research, even though many believe their was, because the MSM reported it that way.

[SuziQ]

Oh my, that interview with Shelby Steele was awesome. He states what I’d thought about why so many white people voted for Obama, to assuage their guilt about slavery, and civil rights, and to be able to tell people that they were not racists, cause “see, I voted for the black man”! Sounds like Shelby underestimated the numbers of white folks who felt that way.

[STARWISE]

Isn’t he and it incredible? I love him,
and he’s got 0 down pat. It’s frightening
forensic analysis, tho.

[pillut48]

Psalm 139 The All-Knowing, Ever-Present God

13 For it was You who created my inward parts; You knit me together in my mother's womb.

14 I will praise You, because I have been remarkably and wonderfully made. Your works are wonderful, and I know [this] very well.

15 My bones were not hidden from You when I was made in secret, when I was formed in the depths of the earth.

16 Your eyes saw me when I was formless; all [my] days were written in Your book and planned before a single one of them began.

(Holman Christian Standard Bible version from bible.com)

[AliVeritas]

Sure, we saw how the scientific edge worked out by exporting the Buck case and other eugenic examples over to Hitler (after they fell flat across the pond). That Sanger was really loved over there too. See the Groningen Protocol, you should love that... what scientific progress.

Science itself has proven in over 400 documented cases the effectiveness of adult vs. none in ESRC.

I know two people involved in a study here in NYC six years ago, one is no longer with us; The problem with pluripotent is the lack of control re: growth... hence tumors, death. Yale, Columbia, Mt. Sinai and others have ran many trials as well.

Lastly, when you see a society clamoring for socialized medicine, you’re not going to get more research (feds).
If you do, it’s not for the greater good, but culling.

Thanks for the materialistic worldview btw. /s

[demshateGod]

McCain was a HUGE proponent of embryonic stem cell research and was constantly using the lefts rhetoric against Bush.